Treatment of female urinary incontinence has been attempted by various methods and devices throughout the decades. Generally, physicians have endeavored to exercise various puncture techniques wherein the wall of the vagina is undesirably disturbed and damaged.
Typically, female urinary incontinence is remedied with tying the urethro-vesical junction to the back of the symphysis pubis. With existing surgical devices, physicians have had few options to conduct alternative medical procedures. Moreover, traditional medical procedures have always involved application of general anesthesia because of the invasive nature of the remedial action.
One of the most famous treatments for female urinary incontinence is the Perayra technique. The original Pereyra technique used No. 30 stainless wire, which was looped through the vagina without a vaginal incision, by the blind passage of a specially designed needle through a suprapubic incision.
In the modified Pereyra procedure, the superior wall of the vagina is sutured to the abdominal wall rather than structured in the retropubic region. The modified Pereyra procedure involves the use of a ligature carrier having a brace to guide a retractable needle for extension and retraction. The trace includes a generally flat serrated or striated brace handle from which parallel guides extend back, away from the needle tip. The needle's end is angulated and has an eye at its tip. The needle slides through a hole in the brace handle. As has been recounted in prior art of record, there exist numerous explanations for high failure rates of the Pereyra procedure.
In another treatment, the Burch Procedure, the vaginal fascia used to elevate the urethro-vesical angle and the vaginal fascia near the urethra are sutured to Cooper's ligament, ilecpectineal ligament after dissection in retzius space.
Endoscopic suspension was first described in 1973 by Stamey. The innovation was to emphasize the use of the cystoscope to control accurate placement of the suspending sutures in his technique. A T-shaped vaginal incision is made in the anterior vaginal wall and the periurethral tissue exposed. Then, through a short suprapubic incision, the specially designed Stamey needle is introduced through the rectus fascia with the needle in place. Cystoscopic inspection is performed with movement of the needle. Small dacron buttresses are used to prevent suture pull through. Dacron tubes are used to buttress the endopelvic fascia.
Gitte and Laughlin, in 1988, modified the Stamey procedure by making no vaginal incision at all. Instead, they allow the monofilament nylon suture through the vaginal epithelium. In this technique, permanent sutures are withdrawn by a long suspension needle retropubically to the stab incision, where they are secured to fat. It is suggested that over time, the sutures pull through the subcutaneous tissues and then become attached to the rectus fascia with appropriate tension. Vaginal repithelization occurs over these sutures.
None of the previous tools, in combination with any of the aforementioned techniques for treating female urinary incontinence, has been suitable for conducting a procedure which can be performed without an incision on the vaginal wall. Furthermore, none of such tools, in combination with any procedures, has featured an absence of anchoring of the bladder neck suspension and suture to the anterior rectus fascia.
In a new approach, to avert postoperative pain syndrome due to nerve entrapment, the present invention is utilized to anchor the bladder neck with suspending sutures to the edge of pubic bone on the scarpa fascia and rectus abdominus tendinous plus Cooper ligament. It is recognized that the present invention has been specially adapted to serve as a necessary apparatus for successfully performing the new procedure. As a result of employing the present invention in combination with the new procedure, a surgeon should expect patients to exhibit increased support and remarkable scarification after operations.
To understand the setting in which the present invention functions, the new operation procedure is herein described for reference. First, a special long suspension needle is passed through the anterior scarpa fascia, then the rectus tendinous abdominus and the Cooper ligament, toward the undersurface of the symphysis pubis, the retropubic fat pad and the endopelvic fascia and the vaginal wall into the vagina, lateral to the urethrovesical junction, under direct finder guidance. A No. 2 monofilament nylon suture is threaded through the needle's eye, withdrawn to the suprapubic port, and tagged with a hemostat clamp.
Next, the vaginal side tail of the nylon suture is loaded with a Mayo or curve needle. The suture is placed in a circular or spiral fashion incorporating full thickness in the vaginal wall 1-1.5 cm on the lateral side of the urethrovesical level. The suture end is replaced on the long needle eye and withdrawn through the second puncture on the junction of the scarpa fascia and the edge of the symphysis pubis, 1 cm from the first puncture and tagged with hemostat.
In this technique, no vaginal incision is necessary because the suture buries itself by gradually penetrating through the vaginal epithelium and then making remarkable scarification on the endopelvic ligament and the retropubic structure, plus on the rectus abdominus tendinous, the Cooper ligament, and the scarpa fascia on the edge of the pubic bone under subcutaneous fat. At the time treat the surgeon passes the suspension needle through the lateral edges of the incision, he leaves a bridge of the scarpa fascia, the rectus abdominus tendinous, and the Cooper ligament, between the suspending sutures, for suspension at the end of cystoscopy. The cystoscopy is performed to help assure that there has been no injury to the bladder.
The rigid cystoscopy assists in confirming that adequate support has been given to the urethra and bladder neck. If the suspension sutures have unintentionally penetrated the bladder wall, such a case is noticed at the time so the cystoscopy and suture can be pulled out and the operation can be repeated. Also, the lateral aspect or 3, 9 o'clock of the urethrovesical junction and the lower bladder must be seen clearly with no oozing or bleeding and no suture violation. If there is suture violation, the surgeon can pull it cut and re-attempt correct placement. The suprapubic catheter with memory must be placed under the supervision of the cystoscopy surgeon. The catheter must be fixed with several sutures for prevention of dislodging or extravasation. Care must be taken to ensure that the catheter functions satisfactorily.
The monofilament sutures are tied over a reinforced 1-1.5 cm scarpa fascia and the rectus abdominus tendinous attached to the pubic tone. After pushing or bringing the urethrovesical junction to the retropubic space or normal position, moderate tension is required to furnish the support necessary to treat urinary stress incontinence.
In short, a surgeon utilizing the present invention restores the anatomical and physiological position of the proximal urethra, in such a fashion, as to allow transmission of intra-abdominal pressure. Urethral closure pressure is enhanced at least to the same degree and sometimes to a greater degree than normal.
Accordingly, the need arises for a bladder saver retropubic ligature carrier device with a specially designed tip and main body, which allows a physician to exercise increased dexterity and achieve greater operation success.